Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

K-Number: K193007 · 2020-01-17

ApplicantLina Medical Aps
Decision Date2020-01-17
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193007. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Lina Medical Aps. The 510(k) number is K193007.

When did LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module receive FDA 510(k) clearance?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193007.

Who is the listed applicant for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

The FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is HIH.

Other records listing Lina Medical Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)K223932SafeAir combi (SFR-combi-US)K221085LiNA OperaScope NeedleK182224SafeAir Smoke Evacuator compactK182354SafeAir Telescopic Smoke PencilK171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

View all 7 devices →

Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑